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Medicare Administrative Procedure Act Centers for Medicare & Medicaid Services (CMS)

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check July 2025

Ropes & Gray LLP on

In the early days of the second Trump Administration, several federal funding agencies announced caps to indirect cost (“IDC”) rates for federally funded research awards. In many cases, these caps would substantially reduce...more

Mintz - Health Care Viewpoints

Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more

Whiteford

Client Alert: Court Strikes Down Nursing Home Staffing Mandate

Whiteford on

In a major victory for nursing homes and long-term care industry advocates, on Monday, April 7, 2025, Judge Matthew J. Kacsmaryk of the US District Court for Northern Texas struck down a Centers for Medicare & Medicaid...more

Arnall Golden Gregory LLP

U.S. Department of Health and Human Services Rescinds "Richardson Waiver" Policy

On March 3, 2025, the U.S. Department of Health and Human Services (“HHS”) announced a new policy to reverse course on certain public notice and comment procedures. This marks a significant change to a process in place for...more

Proskauer - Health Care Law Brief

HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking

On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more

Foley Hoag LLP

Department of Health and Human Services Seeks to Revise Rulemaking Policies

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On Friday, February 28, 2025, the Department of Health and Human Services (HHS) issued a policy statement announcing changes to rulemaking processes for agencies within HHS. According to the statement, HHS is rescinding a...more

Hogan Lovells

HHS rescinds policy regarding notice-and-comment rulemaking – implications for health care industry

Hogan Lovells on

On February 28, 2025, the Department of Health and Human Services (“HHS” or “the Department”) issued a Policy Statement rescinding long-standing HHS guidance regarding the use of notice-and-comment rulemaking to adopt certain...more

Mintz - Health Care Viewpoints

Mintz IRA Update — A Circuit Win and the End of Chevron Deference Could Shift Tides in Drug Price Negotiation Program Challenges

As detailed in our previous updates, the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program or Program), which enables the federal government to negotiate prices for some of the costliest Medicare Part D...more

Arnall Golden Gregory LLP

Lawsuit Challenges Hospice Special Focus Program Rule and List

A group of four state associations and a hospice provider have filed a federal lawsuit in Texas challenging the Special Focus Program (“SFP”) Final Rule and the resulting list of hospices identified as poor performers. The...more

Mintz - Health Care Viewpoints

EnforceMintz — Medicare Advantage and Part D Programs to Remain in the Enforcement Spotlight in 2025

As government scrutiny and enforcement targeting the Medicare Advantage (Medicare Part C) program continued in 2024, the industry’s response to agency actions escalated. Last year also resulted in the first sizable Part D...more

King & Spalding

Ninth Circuit Vacates Low-Wage-Index Policy

King & Spalding on

On December 11, 2024, the Ninth Circuit struck down an HHS policy that boosted the wage index, and therefore the Medicare reimbursement rate, for hospitals in low-income communities in Kaweah Delta Health Care District v....more

Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

Akin Gump Strauss Hauer & Feld LLP

Happy Birthday Two You, IRA: Drug Pricing Dynamics to Watch as Maximum Fair Price Announcements Loom

This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...more

Bradley Arant Boult Cummings LLP

The Overturn of Chevron: A New Design for Healthcare Law

On June 28, 2024, SCOTUS overturned the long-standing Chevron doctrine in its decision Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce. The Court’s ruling will have a significant impact on...more

Stevens & Lee

A New Arena for Future Challenges to CMS Regulations – the Overturn of Chevron

Stevens & Lee on

On June 28, 2024, the Supreme Court overruled Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., and consequently invalidated the “Chevron Deference” — a cornerstone of administrative law since 1984. In the 6-3 decision...more

Polsinelli

Provider Reimbursement Disputes Go Back to 1984 Following Supreme Court’s Regulatory Reset

Polsinelli on

One could forgive the healthcare industry for thinking someone drove Doc Brown’s DeLorean time machine through One First Street when it awoke on Friday, June 28, to a blast from the past....more

Mintz - Health Care Viewpoints

The Uncertain Landscape of Medicare Agent/Broker Compensation Rules

In the Proposed Medicare Advantage and Part D Rules for 2025, the Centers for Medicare & Medicaid Services (CMS) proposed significant changes to how Medicare Advantage organizations (MAOs) are allowed to contract with and...more

Foley & Lardner LLP

What Does the End of Chevron Deference Mean for Federal Health Care Programs?

Foley & Lardner LLP on

On June 28, 2024, the Supreme Court rejected the doctrine of Chevron deference in the closely watched case of Loper Bright Enterprises v. Raimondo. In a 6-3 decision, the Court held that Chevron’s rule that courts must defer...more

Knobbe Martens

Medicare Drug Price Negotiation Program Steadily Progressing Despite Lawsuits

Knobbe Martens on

The Biden Administration’s Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices with drugmakers, has faced several legal challenges....more

Goodwin

Court Grants Summary Judgment Ending AstraZeneca’s Lawsuit Challenging the IRA

Goodwin on

Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program...more

Goodwin

IRA Drug Price Negotiation Program Litigation Updates - Denial of PI Motion and Motion to Dismiss in Chambers of Commerce Case and...

Goodwin on

Denial of Motion to Dismiss and Motion for Preliminary Injunction in Chambers of Commerce case - On Friday, September 29, the court in Dayton Area Chamber of Commerce et al. v. Becerra et al. (S.D. Ohio, Judge Newman)...more

Mintz - Health Care Viewpoints

PAMA Laboratory Reporting In Flux: ACLA Wins HHS Lawsuit and Congress Introduces PAMA Amendment Legislation

Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred. As a result, the clinical laboratory...more

King & Spalding

Federal COVID-19 Mandates and Lawsuit Roundup

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Lawsuits challenging the CMS Interim Final Rule (IFR) on COVID-19 vaccine requirements for healthcare workers and Occupational Safety and Health Administration’s (OSHA) COVID-19 Emergency Temporary Standards on Health Care...more

Womble Bond Dickinson

The Biden Administration Expands Staff Vaccination Requirement to All Medicare & Medicaid Participating Providers/Suppliers.

Womble Bond Dickinson on

The Biden Administration, through the Centers for Medicare and Medicaid Services (“CMS”) and via Interim Final Rulemaking (“IFR”), has expanded vaccination requirements in many health care settings. Effective November 5,...more

King & Spalding

D.C. District Court Upholds HHS’s Audits of Hospitals’ Worksheet S-10 and Resulting Adjustments When Determining Medicare DSH...

King & Spalding on

On August 30, 2021, the United States District Court for the District of Columbia ruled in favor of HHS and dismissed claims related to improper audits that resulted in adjustments to plaintiff hospitals’ Worksheet S-10 that...more

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